BluSense Diagnostics is a young and dynamic MedTech company, spin-off in 2015 from the Department of Micro- and Nanotechnology, Technical University of Denmark. The company is developing a point-of-care blood testing device for infectious diseases, based on a novel nanotechnology-based biosensing method, leveraging hardware and consumables developed from the optical storage industry.

Do you possess a strong team spirit and enthusiasm?

Would you like to work in an international, fast-paced environment with cross-functional teams?

Do you have a technical background, with 4+ years of industry experience in medical device production/process development and validation environment?

If yes, we want to hear from you now!

The position:

BluSense Diagnostics is developing the next generation of point-of-care testing for infectious diseases, focusing on mosquito-borne diseases such as dengue and Zika. Our main product is a polymer consumable microfluidic cartridge containing dry biochemical reagents that we assemble entirely in house.

To ramp up production volumes of these polymer consumables and to strengthen our process development and engineering team, we are looking for a Process Development and Validation Specialist. We are offering a position within a fast-growing MedTech company, with operations in both Denmark and Taiwan.

The ideal candidate will work side by side with a Senior Engineer responsible for the technical process development and will work closely with the R&D and Production department while keeping strong collaboration with the Quality Assurance department. The right candidate will work on improving the documentation and validation of the current production line and will be responsible for the coordination of the process development and validation activity of a new production line.

Responsibilities:

• Responsible for coordination of process development and validation activities at BluSense
• Responsible for defining, together with the rest of the engineering team, equipment requirements (e.g. URS) and keeping communication with suppliers
• Perform FAT and SAT of production equipment
• Together with the production department perform IQ, OQ and PQ of production equipment
• Participate in projects (mainly during design transfer and Launch preparation) as Process Validation responsible
• Lead process validation activities in collaboration with the relevant Project manager and Manufacturing Lead
• Ability to interface with the QA department towards the creation /update of production documentation 
• Support the training of users on the processes within R&D and production
• Improve the procedures for process validation to fulfil internal and external requirements, ensuring validation documentation content is understandable and defendable during inspections and audits
• Lead the creation and maintenance of Risk documentation (e.g. FMEA)
• Lead the creation and maintenance of Process Validation Master Plans and lead related change request processes
• Lead re-qualification/re-validation activities on current production processes and related documentation
• Participate in the Change Management process as reviewer/approver of associated Risk assessments

Qualifications:

• Technical background, with 4+ years of industry experience in medical device production/process development and validation environment
• Relevant work experience within process development and validation in the medical/IVD/microfluidic consumables industry 
• Basic computer skills and familiarity with Microsoft Windows, Word and Excel
• Must be familiar with GLP, ISO 13485:2016 and current EU IVD Directive
• Previous experience in the development and validation of a complete production line is considered a plus
  

Personal skills:

• Fluency in English, both verbally and in writing
• Ability to work in an international environment with cross-functional teams in a fast-paced environment
• Strong team spirit and enthusiasm 

We offer:

• A challenging and very dynamic working environment 
• Co-operation and exchange of ideas within a multinational and interdisciplinary team
• Professional and personal development in being part of scaling up production operations of an international high-tech company

We will process applications as they arrive. Therefore, please submit your application and CV as soon as possible and no later than March 31th. Qualified applicants can expect to be called for an interview before the deadline.

For further questions related to this position, please contact Marco Donolato, CSO (marco@blusense-diagnostics.com).